A comparative cost analysis of two screening strategies for colorectal cancer in Lynch Syndrome in a South African tertiary hospital.

AIM: Lynch Syndrome (LS) individuals have a 25-75% lifetime risk of developing colorectal cancer. Colonoscopy screening decreases this risk. This study compared the cost of Strategy 1: screening colonoscopy for 1st degree relatives of patients that met the Revised Bethesda Criteria (i.e., probands) to Strategy 2: screening colonoscopy for 1st degree relatives of probands with genetic mutations for Lynch Syndrome based in a resource-constrained health care system. METHOD: A comparative, health care provider perspective, cost analysis was conducted at a tertiary hospital, using a micro-costing, ingredient approach. Forty probands that underwent genetic testing between November 01, 2014 and October 30, 2015 and their first-degree relatives were costed according to Strategy 1 and Strategy 2. Unit costs of colonoscopy and genetic testing were estimated and used to calculate and compare the total costs per strategy in South African rand (R) converted to UK pounds (£). Sensitivity analyses were performed on colonoscopy adherence, relatives' positivity, and variable discount rates. RESULTS: The cost for Strategy 1 amounted to £653 344/R6 161 035 compared to £49 327/R 465 155 for Strategy 2 (Discount rate 3%; Adherence 75%; and Positivity rate of relatives 45%). Base case analysis indicated a difference of 92% less in the total cost for Strategy 2 compared to Strategy 1. Sensitivity analyses showed that the difference in cost between the two strategies was not sensitive to variations in adherence, positivity or discount rates. CONCLUSION: Colonoscopy screening for LS and at-risk family members was tenfold less costly when combined with genetic analysis. The logistics of rolling out this strategy nationally should be investigated.

Assessment of the implementation context in preparation for a clinical study of machine-learning algorithms to automate the classification of digital cervical images for cervical cancer screening in resource-constrained settings.

Introduction: We assessed the implementation context and image quality in preparation for a clinical study evaluating the effectiveness of automated visual assessment devices within cervical cancer screening of women living without and with HIV. Methods: We developed a semi-structured questionnaire based on three Consolidated Framework for Implementation Research (CFIR) domains; intervention characteristics, inner setting, and process, in Cape Town, South Africa. Between December 1, 2020, and August 6, 2021, we evaluated two devices: MobileODT handheld colposcope; and a commercially-available cell phone (Samsung A21ST). Colposcopists visually inspected cervical images for technical adequacy. Descriptive analyses were tabulated for quantitative variables, and narrative responses were summarized in the text. Results: Two colposcopists described the devices as easy to operate, without data loss. The clinical workspace and gynecological workflow were modified to incorporate devices and manage images. Providers believed either device would likely perform better than cytology under most circumstances unless the squamocolumnar junction (SCJ) were not visible, in which case cytology was expected to be better. Image quality (N = 75) from the MobileODT device and cell phone was comparable in terms of achieving good focus (81% vs. 84%), obtaining visibility of the squamous columnar junction (88% vs. 97%), avoiding occlusion (79% vs. 87%), and detection of lesion and range of lesion includes the upper limit (63% vs. 53%) but differed in taking photographs free of glare (100% vs. 24%). Conclusion: Novel application of the CFIR early in the conduct of the clinical study, including assessment of image quality, highlight real-world factors about intervention characteristics, inner clinical setting, and workflow process that may affect both the clinical study findings and ultimate pace of translating to clinical practice. The application and augmentation of the CFIR in this study context highlighted adaptations needed for the framework to better measure factors relevant to implementing digital interventions.

Contraceptive needs and fertility intentions of women with breast cancer in Cape Town, South Africa: a qualitative study.

BACKGROUND: No known studies have been undertaken in South Africa exploring the contraceptive and fertility needs and preferences of women of reproductive age (18-49) diagnosed with breast cancer. This study set out to understand the contraceptive needs and fertility intentions of women with breast cancer in Cape Town, South Africa. METHODS: Qualitative in-depth interviews were conducted with 24 women diagnosed with breast cancer and 4 health care providers at a tertiary hospital in Cape Town, South Africa. We explored contraceptive use prior to diagnosis; the impact of breast cancer on future fertility intentions and contraceptive use; understanding of suitable contraceptive methods during and after treatment and women's fertility related counseling needs during their continuum of care. Data were analysed using a thematic analysis approach. RESULTS: Since being diagnosed with breast cancer, of those women using a contraceptive method, the non-hormonal intrauterine device (IUD) was the most commonly used method. However, women reported receiving limited information from health care providers about contraceptive use and future fertility planning post treatment when fertility desires might change. Many women reported limited information received from healthcare providers about the impact of cancer treatment on their future fertility. Most women did not receive information around fertility preservation options, and few were familiar with the concept. Providers focus was more on preventing pregnancy during treatment and ensuring a patient was on a non-hormonal contraceptive method. Providers supported a more holistic, multidisciplinary approach to breast cancer patient's contraceptive and future fertility needs. CONCLUSIONS: Limited contraceptive and future fertility counseling were reported by women despite many women being provided with the IUD. There is a need for improved information and counseling regarding the impact of treatment on contraceptive and fertility options. It is important that cancer care providers provide timely information regarding fertility options and communicate with patients about their fertility concerns prior to treatment and throughout the course of survivorship. The development of evidence-based information tools to enhance patient-provider communication and counseling could address knowledge gaps.

Accuracy of gestational age estimation from last menstrual period among women seeking abortion in South Africa, with a view to task sharing: a mixed methods study.

BACKGROUND: The requirement for ultrasound to establish gestational age among women seeking abortion can be a barrier to access. Last menstrual period dating without clinical examination should be a reasonable alternative among selected women, and if reliable, can be task-shared with non-clinicians. This study determines the accuracy of gestational age estimation using last menstrual period (LMP) assessed by community health care workers (CHWs), and explores providers' and CHWs' perspectives on task sharing this activity. The study purpose is to expand access to early medical abortion services. METHODS: We conducted a multi-center cross-sectional study at four urban non-governmental reproductive health clinics in South Africa. CHWs interviewed women seeking abortion, recorded their LMP and gestational age from a pregnancy wheel if within 63 days. Thereafter, providers performed a standard examination including ultrasound to determine gestational age. Lastly, investigators calculated gestational age for all LMP dates recorded by CHWs. We compared mean gestational age from LMP dates to mean gestational age by ultrasound using t-tests and calculated proportions for those incorrectly assessed as eligible for medical abortion from LMP. In addition, in-depth interviews were conducted with six providers and seven CHWs. RESULTS: Mean gestational age was 5 days (by pregnancy wheel) and 9 days (by LMP calculation) less than ultrasound gestational age. Twelve percent of women were eligible for medical abortion by LMP calculation but ineligible by ultrasound. Uncertainty of LMP date was associated with incorrect assessment of gestational age eligibility for medical abortion (p = 0.015). For women certain their LMP date was within 56 days, 3% had ultrasound gestational ages >70 days. In general, providers and CHWs were in favour of task sharing screening and referral for abortion, but were doubtful that women reported accurate LMP dates. Different perspectives emerged on how to implement task sharing gestational age eligibility for medical abortion. CONCLUSIONS: If LMP recall is within 56 days, most women will be eligible for early medical abortion and LMP can substitute for ultrasound dating. Task sharing gestational age estimation is feasible in South Africa, but its implementation should meet women's privacy needs and address healthcare workers' concerns on managing any procedural risk.

Coming of age? Women's sexual and reproductive health after twenty-one years of democracy in South Africa.

This paper is a sequel to a 2004 article that reviewed South Africa's introduction of new sexual and reproductive health (SRH) and rights laws, policies and programmes, a decade into democracy. Similarly to the previous article, this paper focuses on key areas of women's SRH: contraception and fertility, abortion, maternal health, HIV, cervical and breast cancer and sexual violence. In the last decade, South Africa has retained and expanded its sexual and reproductive health and rights (SRHR) policies in the areas of abortion, contraception, youth and HIV treatment (with the largest antiretroviral treatment programme in the world). These are positive examples within the SRHR policy arena. These improvements include fewer unsafe abortions, AIDS deaths and vertical HIV transmission, as well as the public provision of a human papillomavirus vaccine to prevent cervical cancer. However, persistent socio-economic inequities and gender inequality continue to profoundly affect South African women's SRHR. The state shows mixed success over the past two decades in advancing measurable SRH social justice outcomes, and in confronting and ameliorating social norms that undermine SRHR.

Accuracy of Assessment of Eligibility for Early Medical Abortion by Community Health Workers in Ethiopia, India and South Africa.

OBJECTIVE: To assess the accuracy of assessment of eligibility for early medical abortion by community health workers using a simple checklist toolkit. DESIGN: Diagnostic accuracy study. SETTING: Ethiopia, India and South Africa. METHODS: Two hundred seventeen women in Ethiopia, 258 in India and 236 in South Africa were enrolled into the study. A checklist toolkit to determine eligibility for early medical abortion was validated by comparing results of clinician and community health worker assessment of eligibility using the checklist toolkit with the reference standard exam. RESULTS: Accuracy was over 90% and the negative likelihood ratio <0.1 at all three sites when used by clinician assessors. Positive likelihood ratios were 4.3 in Ethiopia, 5.8 in India and 6.3 in South Africa. When used by community health workers the overall accuracy of the toolkit was 92% in Ethiopia, 80% in India and 77% in South Africa negative likelihood ratios were 0.08 in Ethiopia, 0.25 in India and 0.22 in South Africa and positive likelihood ratios were 5.9 in Ethiopia and 2.0 in India and South Africa. CONCLUSION: The checklist toolkit, as used by clinicians, was excellent at ruling out participants who were not eligible, and moderately effective at ruling in participants who were eligible for medical abortion. Results were promising when used by community health workers particularly in Ethiopia where they had more prior experience with use of diagnostic aids and longer professional training. The checklist toolkit assessments resulted in some participants being wrongly assessed as eligible for medical abortion which is an area of concern. Further research is needed to streamline the components of the tool, explore optimal duration and content of training for community health workers, and test feasibility and acceptability.

The HIV epidemic and sexual and reproductive health policy integration: views of South African policymakers.

BACKGROUND: Integration of sexual and reproductive health (SRH) and HIV policies and services delivered by the same provider is prioritised worldwide, especially in sub-Saharan Africa where HIV prevalence is highest. South Africa has the largest antiretroviral treatment (ART) programme in the world, with an estimated 2.7 million people on ART, elevating South Africa's prominence as a global leader in HIV treatment. In 2011, the Southern African HIV Clinicians Society published safer conception guidelines for people living with HIV (PLWH) and in 2013, the South African government published contraceptive guidelines highlighting the importance of SRH and fertility planning services for people living with HIV. Addressing unintended pregnancies, safer conception and maternal health issues is crucial for improving PLWH's SRH and combatting the global HIV epidemic. This paper explores South African policymakers' perspectives on public sector SRH-HIV policy integration, with a special focus on the need for national and regional policies on safer conception for PLWH and contraceptive guidelines implementation. METHODS: It draws on 42 in-depth interviews with national, provincial and civil society policymakers conducted between 2008-2009 and 2011-2012, as the number of people on ART escalated. Interviews focused on three key domains: opinions on PLWH's childbearing; the status of SRH-HIV integration policies and services; and thoughts and suggestions on SRH-HIV integration within the restructuring of South African primary care services. Data were coded and analysed according to themes. RESULTS: Participants supported SRH-HIV integrated policy and services. However, integration challenges identified included a lack of policy and guidelines, inadequately trained providers, vertical programming, provider work overload, and a weak health system. Participants acknowledged that SRH-HIV integration policies, particularly for safer conception, contraception and cervical cancer, had been neglected. Policymakers supported public sector adoption of safer conception policy and services. Participants interviewed after expanded ART were more positive about safer conception policies for PLWH than participants interviewed earlier. CONCLUSION: The past decade's HIV policy changes have increased opportunities for SRH-HIV integration. The findings provide important insights for international, regional and national SRH-HIV policy and service integration initiatives.

A bibliometric analysis of cancer research in South Africa: study protocol.

INTRODUCTION: Cancer is an important and growing public health burden in South Africa (SA). Over the past few decades, there has been considerable scientific activity in cancer in SA. However, there has been limited analysis of cancer scientific publications. In this paper, we present a protocol for bibliometric analysis of cancer research conducted in SA. METHODS AND ANALYSIS: A comprehensive search of the journal databases PubMed, SCOPUS, Web of Science and EBSCO will be conducted to identify and retrieve data from primary peer-reviewed cancer research articles using a set of consensus search words. Articles that involve cancer research conducted in SA or using biological or clinical data from South African participants and published between 2004 and 2014 will be included in the study. Two independent researchers will screen the articles for eligibility. Bibliometric indicators and study characteristics will be extracted, entered into a database and analysed. The cancer disease site will be recorded and research will be classified using the Common Scientific Outline system. Data obtained will be analysed to determine SA's publication productivity index in cancer research. Annual trends in bibliometric indicators and the type of cancer research will be determined. The degree of collaboration in research conducted in SA will be analysed using co-authorship matrix software. A publication to disease type ratio will be used to assess scientific production relative to disease burden. ETHICS AND DISSEMINATION: As this analysis will draw on publicly available data and does not directly involve human participants, ethical review is not required. We anticipate that the bibliometric analysis will identify the trends in cancer research productivity and the extent to which cancer research is aligned to the local burden of disease. Results will be published in peer-reviewed journals and presented in a user-friendly format to relevant policymakers and funders.

Expanding contraceptive options for PMTCT clients: a mixed methods implementation study in Cape Town, South Africa.

BACKGROUND: Clients of prevention of mother-to-child transmission (PMTCT) services in South Africa who use contraception following childbirth rely primarily on short-acting methods like condoms, pills, and injectables, even when they desire no future pregnancies. Evidence is needed on strategies for expanding contraceptive options for postpartum PMTCT clients to include long-acting and permanent methods. METHODS: We examined the process of expanding contraceptive options in five health centers in Cape Town providing services to HIV-positive women. Maternal/child health service providers received training and coaching to strengthen contraceptive counseling for postpartum women, including PMTCT clients. Training and supplies were introduced to strengthen intrauterine device (IUD) services, and referral mechanisms for female sterilization were reinforced. We conducted interviews with separate samples of postpartum PMTCT clients (265 pre-intervention and 266 post-intervention) to assess knowledge and behaviors regarding postpartum contraception. The process of implementing the intervention was evaluated through systematic documentation and interpretation using an intervention tracking tool. In-depth interviews with providers who participated in study-sponsored training were conducted to assess their attitudes toward and experiences with promoting voluntary contraceptive services to HIV-positive clients. RESULTS: Following the intervention, 6% of interviewed PMTCT clients had the desired knowledge about the IUD and 23% had the desired knowledge about female sterilization. At both pre- and post-intervention, 7% of clients were sterilized and IUD use was negligible; by comparison, 75% of clients used injectables. Intervention tracking and in-depth interviews with providers revealed intervention shortcomings and health system constraints explaining the failure to produce intended effects. CONCLUSIONS: The intervention failed to improve PMTCT clients' knowledge about the IUD and sterilization or to increase use of those methods. To address the family planning needs of postpartum PMTCT clients in a way that is consistent with their fertility desires, services must expand the range of contraceptive options to include long-acting and permanent methods. In turn, to ensure consistent access to high quality family planning services that are effectively linked to HIV services, attention must also be focused on resolving underlying health system constraints weakening health service delivery more generally.

The potential cost-effectiveness of adding a human papillomavirus vaccine to the cervical cancer screening programme in South Africa.

This study was designed to answer the question of whether a cervical cancer prevention programme that incorporates a human papillomavirus (HPV) vaccine is potentially more cost-effective than the current strategy of screening alone in South Africa. We developed a static Markov state transition model to describe the screening and management of cervical cancer within the South African context. The incremental cost-effectiveness ratio of adding HPV vaccination to the screening programme ranged from US $1078 to 1460 per quality-adjusted life year (QALY) gained and US$3320-4495 per life year saved, mainly depending on whether the study was viewed from a health service or a societal perspective. Using discounted costs and benefits, the threshold analysis indicated that a vaccine price reduction of 60% or more would make the vaccine plus screening strategy more cost-effective than the screening only approach. To address the issue of affordability and cost-effectiveness, the pharmaceutical companies need to make a commitment to price reductions.

Fertility intentions and reproductive health care needs of people living with HIV in Cape Town, South Africa: implications for integrating reproductive health and HIV care services.

Tailoring sexual and reproductive health services to meet the needs of people living with the human immuno-deficiency virus (HIV) is a growing concern but there are few insights into these issues where HIV is most prevalent. This cross-sectional study investigated the fertility intentions and associated health care needs of 459 women and men, not sampled as intimate partners of each other, living with HIV in Cape Town, South Africa. An almost equal proportion of women (55%) and men (43%) living with HIV, reported not intending to have children as were open to the possibility of having children (45 and 57%, respectively). Overall, greater intentions to have children were associated with being male, having fewer children, living in an informal settlement and use of antiretroviral therapy. There were important gender differences in the determinants of future childbearing intentions, with being on HAART strongly associated with women's fertility intentions. Gender differences were also apparent in participants' key reasons for wanting children. A minority of participants had discussed their reproductive intentions and related issues with HIV health care providers. There is an urgent need for intervention models to integrate HIV care with sexual and reproduction health counseling and services that account for the diverse reproductive needs of these populations.

Preparing for HPV vaccination in South Africa: key challenges and opinions.

This article reports on qualitative research investigating key challenges and barriers towards human papillomavirus (HPV) vaccine introduction in the Western Cape Province, South Africa. A total of 50 in-depth interviews and 6 focus groups were conducted at policy, health service and community levels of enquiry. Respondents expressed overall support for the HPV vaccine, underscored by difficulties associated with the current cervical screening programmes and the burgeoning HIV/AIDS epidemic in South Africa. Overall poor community knowledge of cervical cancer and the causal relationship between HPV and cervical cancer suggests the need for continued education around the importance of regular cervical screening. The optimal target populations for HPV vaccination was influenced by the perceived median age of sexual activity in South African girls (9-15 years), with an underlying concern that high levels of sexual abuse had significantly decreased the age of sexual exposure suggesting vaccination should commence as early as 9 years. Vaccination through schools with the involvement of other stakeholders such as sexual and reproductive health and the advanced programme on immunization (EPI) were suggested. Opposition to the HPV vaccine was not anticipated if the vaccine was marketed as preventing cervical cancer rather than a sexually transmitted infection. The findings assist in identifying potential barriers and facilitating factors towards HPV vaccines and will inform the development of policy and programs to support HPV vaccination introduction in South Africa and other African countries.

Ten years of democracy in South Africa: documenting transformation in reproductive health policy and status.

The advent of democracy in South Africa in 1994 created a unique opportunity for new lows and policies to be passed. Today, a decade later, South African reproductive health policies and the laws that underwrite them are among the most progressive and comprehensive in the world in terms of the recognition that they give to human rights, including sexual and reproductive rights. This paper documents the changes in health policy and services that have occurred, focusing particularly on key areas of sexual and reproductive health: contraception, maternal health, termination of pregnancy, cervical and breast cancer, gender-based and sexual violence, HIV/AIDS and sexually transmitted infections and infertility. Despite important advances, significant changes in women's reproductive health status are difficult to discern, given the relatively short period of time and the multitude of complex factors that influence health, especially inequalities in socio-economic and gender status. Gaps remain in the implementation of reproductive health policies and in service delivery that need to be addressed in order for meaningful improvements in women's reproductive health status to be achieved. Civil society has played a major role in securing these legislative and policy changes, and health activist groups continue to pressure the government to introduce further changes in policy and service delivery, especially in the area of HIV/AIDS.